EP3980065A1 - Méthode sûre et efficace de traitement de l'arthrite psoriasique au moyen d'un anticorps spécifique anti-il23 - Google Patents

Méthode sûre et efficace de traitement de l'arthrite psoriasique au moyen d'un anticorps spécifique anti-il23

Info

Publication number
EP3980065A1
EP3980065A1 EP20818188.3A EP20818188A EP3980065A1 EP 3980065 A1 EP3980065 A1 EP 3980065A1 EP 20818188 A EP20818188 A EP 20818188A EP 3980065 A1 EP3980065 A1 EP 3980065A1
Authority
EP
European Patent Office
Prior art keywords
week
antibody
guselkumab
treatment
subject
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20818188.3A
Other languages
German (de)
English (en)
Other versions
EP3980065A4 (fr
Inventor
Elizabeth HSIA
Alexa KOLLMEIER
Xie Xu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Janssen Biotech Inc
Original Assignee
Janssen Biotech Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Janssen Biotech Inc filed Critical Janssen Biotech Inc
Publication of EP3980065A1 publication Critical patent/EP3980065A1/fr
Publication of EP3980065A4 publication Critical patent/EP3980065A4/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Definitions

  • FIG. 12 Shows the median and IQ Range of serum Guselkumab concentrations (pg/mL) through Week 24 by antibody status for study CNT01959PSA3001.
  • an“anti-IL-23 specific antibody,”“anti-IL-23 antibody,”“antibody portion,” or“antibody fragment” and/or“antibody variant” and the like include any protein or peptide containing molecule that comprises at least a portion of an immunoglobulin molecule, such as but not limited to, at least one complementarity determining region (CDR) of a heavy or light chain or a ligand binding portion thereof, a heavy chain or light chain variable region, a heavy chain or light chain constant region, a framework region, or any portion thereof, or at least one portion of an IL-23 receptor or binding protein, which can be incorporated into an antibody of the present invention.
  • CDR complementarity determining region
  • this light chain human germline framework is selected from Vl-11, Vl-13, Vl-16, Vl-17, Vl-18, Vl-19, Vl-2, VI -20, VI -22, Vl-3, Vl-4, Vl-5, Vl-7, Vl-9, V2-1, V2-11, V2-13, V2-14, V2-15, V2-17, V2- 19, V2-6, V2-7, V2-8, V3-2, V3-3, V3-4, V4-1, V4-2, V4-3, V4-4, V4-6, V5-1, V5-2, V5-4, and V5-6.
  • the affinity or avidity of an antibody for an antigen can be determined experimentally using any suitable method. (See, for example, Berzofsky, et al,“Antibody-Antigen
  • the isolated nucleic acids can be made using (a) recombinant methods, (b) synthetic techniques, (c) purification techniques, and/or (d) combinations thereof, as well-known in the art.
  • neutralizing antibody refers to an antibody that can inhibit an IL-23 -dependent activity by about 20-120%, preferably by at least about 10, 20, 30, 40, 50, 55, 60, 65, 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100% or more depending on the assay.
  • the capacity of an anti-IL-23 antibody to inhibit an IL-23 -dependent activity is preferably assessed by at least one suitable IL-23 protein or receptor assay, as described herein and/or as known in the art.
  • Carbohydrate excipients suitable for use in the invention include, for example, monosaccharides, such as fructose, maltose, galactose, glucose, D-mannose, sorbose, and the like; disaccharides, such as lactose, sucrose, trehalose, cellobiose, and the like; polysaccharides, such as raffinose, melezitose, maltodextrins, dextrans, starches, and the like; and alditols, such as mannitol, xylitol, maltitol, lactitol, xylitol sorbitol (glucitol), myoinositol and the like.
  • Preferred carbohydrate excipients for use in the present invention are mannitol, trehalose, and raffinose.
  • the method of the invention uses an article of manufacture, comprising packaging material and at least one vial comprising a solution of at least one anti-IL-23 specific antibody with the prescribed buffers and/or preservatives, optionally in an aqueous diluent, wherein said packaging material comprises a label that indicates that such solution can be held over a period of 1, 2, 3, 4, 5, 6, 9, 12, 18, 20, 24, 30, 36, 40, 48, 54, 60, 66, 72 hours or greater.
  • polyoxyethylene polyoxypropylene block copolymers and PEG (polyethylene glycol) or non ionic surfactants, such as polysorbate 20 or 80 or poloxamer 184 or 188, Pluronic® polyls, other block co-polymers, and chelators, such as EDTA and EGTA, can optionally be added to the formulations or compositions to reduce aggregation. These additives are particularly useful if a pump or plastic container is used to administer the formulation.
  • PEG polyethylene glycol
  • non ionic surfactants such as polysorbate 20 or 80 or poloxamer 184 or 188
  • Pluronic® polyls other block co-polymers
  • chelators such as EDTA and EGTA
  • the formulations can be provided to patients as clear solutions or as dual vials comprising a vial of lyophilized anti-IL-23 specific antibody that is reconstituted with a second vial containing water, a preservative and/or excipients, preferably, a phosphate buffer and/or saline and a chosen salt, in an aqueous diluent.
  • a preservative and/or excipients preferably, a phosphate buffer and/or saline and a chosen salt
  • Either a single solution vial or dual vial requiring reconstitution can be reused multiple times and can suffice for a single or multiple cycles of patient treatment and thus can provide a more convenient treatment regimen than currently available.
  • the present articles of manufacture are useful for administration over a period ranging from immediate to twenty-four hours or greater. Accordingly, the presently claimed articles of manufacture offer significant advantages to the patient.
  • the isolated antibody in one embodiment of the pharmaceutical compositions, the isolated antibody
  • treatment of humans or animals can be provided as a one time or periodic dosage of at least one antibody of the present invention 0.1 to 100 mg/kg, such as 0.5, 0.9, 1.0, 1.1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 40, 45, 50, 60, 70, 80, 90 or 100 mg/kg, per day, on at least one of day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29,
  • Embodiment lb is the method of embodiment 1, wherein the antibody comprises the heavy chain variable region of the amino acid sequence of SEQ ID NO: 7, and the light chain variable region of the amino acid sequence of SEQ ID NO: 8.
  • Embodiment 3h is the method of embodiment 3g, wherein the subject has inadequate response to the at least one biologic treatment.
  • Embodiment 3m is the method of any one of embodiments 1 to 31, optionally further comprising administering to the subject a standard therapy for PsA.
  • Embodiment 5 is the method of any one of embodiments 4-4c, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by a 20% improvement in the American College of Rheumatology core set disease index (ACR20) by week 24 of treatment with the antibody.
  • ACR20 American College of Rheumatology core set disease index
  • Embodiment 5a is the method of any one of embodiments 4-4c, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by a 20% improvement in the American College of Rheumatology core set disease index (ACR20) by week 16 of treatment with the antibody.
  • ACR20 American College of Rheumatology core set disease index
  • Embodiment 5d is the method of any one of embodiments 4-4c, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by a 70% improvement in the American College of Rheumatology core set disease index (ACR70) by week 24 of treatment with the antibody.
  • ACR70 American College of Rheumatology core set disease index
  • Embodiment 10b is the method of embodiment 10, wherein the total dosage is about 100 mg per administration.
  • Embodiment 1 lb is the method of embodiment 11, wherein the the standard therapy is a DMARD selected from the group consisting of methotrexate (MTX) administered to the subject at ⁇ 25 mg/week, sulfasalazine (SSZ) administered to the subject at ⁇ 3 g/day,
  • MTX methotrexate
  • SSZ sulfasalazine
  • Embodiment 13a is the method of any one of embodiments 12- 12c, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by a 20% improvement in the
  • Embodiment 19f is the use of any one of embodiments 19 to 19e, wherein the subject is biologic treatment naive.
  • Embodiment 191 is the use of any one of embodiments 17 to 19j, wherein the subject has at least one psoriatic plaque of >2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis prior to the treatment.
  • IGA Global Assessment
  • Embodiment 26a is the use of embodiment 26, wherein the total dosage is about 50 to about 150 mg per administration.
  • Embodiment 29e is the use of any one of embodiments 28-28c, wherein the subject is a responder to the treatment with the antibody and is identified as having a statistically significant improvement in disease activity as determined by the Health Assessment Questionnaire
  • Embodiment 31 is the use of any one of embodiments 25-30, wherein the anti-IL-23 antibody is guselkumab.
  • mCPDAI Composite Psoriatic Disease Activity Index
  • DAPS A Disease Activity Index for Psoriatic Arthritis
  • PsARC Modified Psoriatic Arthritis Responder Criteria
  • SF-36 36 Item Short- form Health Survey
  • EQ 5D Questionnaire EuroQol five dimensions questionnaire
  • FACIT Functional Assessment of Chronic Illness Therapy
  • the median steady-state trough serum guselkumab concentration was 1.05 pg/mL at Week 20.
  • the median steady-state trough serum guselkumab concentration was 3.35 pg/mL at Week 12 and was maintained through Week 24 (3.98 pg/mL).
  • the steady- state trough serum guselkumab concentrations in the guselkumab 100 mg q4w group were approximately 3- to 4- fold higher compared with those in the guselkumab 100 mg q8w group (FIG.2)
  • both guselkumab treatment groups had a numerically greater proportion of subjects with ACR 20, ACR 50, and ACR 70 responses compared with the placebo group (all nominal p ⁇ 0.001) based on the composite estimand (FIG. 4, FIG. 5, FIG. 6).
  • Subjects with spondylitis and peripheral arthritis at baseline included 86, 73, and 99 subjects in the guselkumab 100 mg q4w, guselkumab 100 mg q8w, and placebo.
  • Subjects with spondylitis and peripheral arthritis at baseline and BASDAI score >0 at baseline included 83, 67, and 92 subjects in the guselkumab 100 mg q4w, guselkumab 100 mg q8w, and placebo groups, respectively.
  • guselkumab 100 mg q8w groups achieved an ACR 20 response at Week 24 compared with subjects in the placebo group (32.9%) based on the global (ex-US) and US-specific multiplicity testing procedures (both adjusted p ⁇ 0.001).
  • Table 24 An overall summary of AEs reported through Week 24 is provided in Table 24. The average number of study agent administrations was consistent across treatment groups.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Rheumatology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

L'invention concerne une méthode de traitement de l'arthrite psoriasique chez le patient par l'administration d'un anticorps spécifique contre IL-23, par exemple le guselkumab, selon une quantité prouvée comme étant cliniquement sûre et cliniquement efficace, qui permet au patient d'atteindre une amélioration significative des critères cliniques, tels que ACR20/50/70, IGA, HAQ-DI, CRP, SF-36 PCS/MCS, MDA, VLDA, l'enthésite, la dactylite et la LEI/dactylite, tels que mesurés 1 et 24 semaines après le traitement initial.
EP20818188.3A 2019-06-04 2020-06-04 Méthode sûre et efficace de traitement de l'arthrite psoriasique au moyen d'un anticorps spécifique anti-il23 Pending EP3980065A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962856997P 2019-06-04 2019-06-04
US202062993259P 2020-03-23 2020-03-23
PCT/IB2020/055278 WO2020245766A1 (fr) 2019-06-04 2020-06-04 Méthode sûre et efficace de traitement de l'arthrite psoriasique au moyen d'un anticorps spécifique anti-il23

Publications (2)

Publication Number Publication Date
EP3980065A1 true EP3980065A1 (fr) 2022-04-13
EP3980065A4 EP3980065A4 (fr) 2023-07-05

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EP20818188.3A Pending EP3980065A4 (fr) 2019-06-04 2020-06-04 Méthode sûre et efficace de traitement de l'arthrite psoriasique au moyen d'un anticorps spécifique anti-il23

Country Status (12)

Country Link
US (2) US20200385453A1 (fr)
EP (1) EP3980065A4 (fr)
JP (2) JP2022536088A (fr)
KR (1) KR20220016954A (fr)
CN (1) CN114025796A (fr)
AU (1) AU2020288749A1 (fr)
BR (1) BR112021024349A2 (fr)
CA (1) CA3142667A1 (fr)
IL (1) IL288496A (fr)
MA (1) MA56124A (fr)
MX (1) MX2021014953A (fr)
WO (1) WO2020245766A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3212729A1 (fr) * 2021-03-12 2022-09-15 Janssen Biotech, Inc. Methode sure et efficace de traitement de l'arthrite psoriasique au moyen d'un anticorps specifique anti-il23
AU2022232007A1 (en) * 2021-03-12 2023-10-26 Janssen Biotech, Inc. Method of treating psoriatic arthritis patients with inadequate response to tnf therapy with anti-il23 specific antibody
WO2023064278A2 (fr) * 2021-10-11 2023-04-20 Y-Trap, Inc. Compositions et procédés qui inhibent la signalisation de l'il-23
KR20250011938A (ko) * 2022-05-18 2025-01-22 얀센 바이오테크 인코포레이티드 Il23 항체에 의해 건선성 관절염을 평가 및 치료하기 위한 방법

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